EBOLA VIRUS DISEASE: MATTERS ARISING

Source: www.md-health.com

EBOLA TIMELINE First discovered in 1976 in Northern Zaire and

Southern Sudan Subsequent outbreaks - Cote d’Ivoire, Gabon

and Uganda 2014 – Most recent outbreak traced to Guinea,

West Africa Spread to Sierra Leone, Liberia, Nigeria and

Senegal Global transmission – Spain, United States of

America

MATTERS ARISING

Ebola

Human Rights

Research

Funding

Clinical Trials

10/90 Gap

10/90 GAP – RESEARCH FUNDING• 10/90 Gap: Only 10% of global health research is devoted to

conditions that account for 90% of the global disease burden.

• Neglected Tropical Diseases: Group of tropical infections which are especially endemic in low-income populations in developing regions of Africa, Asia, and the Americas

• Infectious communicable diseases arising from a diverse group of parasitic worms, bacteria, and vector-borne protozoa.

• Ascariasis, Buruli ulcer, Chagas disease, dracunculiasis, hookworm infection, human African trypanosomiasis, Leishmaniasis, leprosy, lymphatic filariasis, onchocerciasis, schistosomiasis, trachoma, and trichuriasis

• Big three diseases: HIV/AIDS, tuberculosis, and malaria

• Greater funding and research• Ebola?????

NEGLECTED TROPICAL DISEASES BIG THREE DISEASES

• Affects poorest countries of the developing world

• Lesser mortality rate• Long incubation periods• Needs based approach

• High Mortality rate• Public awareness• Market based approach

INCENTIVES• Public private partnerships - the Sabin Vaccine

Institute, Norvartis Vaccines Institute for Global Health, MSD Wellcome Trust Hilleman Laboratories, Infectious Diseases Research Institute, Institut Pasteur and INSERM, and the International Vaccine Institute

• Priority vouchers to speed drug approval processes - Novartis' Coartem, Asset

• Open source scientific collaborations – Malaria GEN, WIPO Re:Search. Copyright matters, SPC

• Global R&D capacity building - Capacity building is the process through which individuals, organizations and societies obtain, strengthen and maintain their capabilities to support development. In practice it encompasses human resources development, institutional development, and the creation of appropriate policy and legal frameworks.

The Special Program for Research and Training in Tropical Diseases (TDR) is a global program of scientific collaboration that helps coordinate, support and influence global efforts to combat a portfolio of major diseases of the poor and disadvantaged. Established in 1975, TDR is based at and executed by the World Health Organization (WHO), and is sponsored by the United Nations Children's Fund (UNICEF), the United Nations Development Program (UNDP), the World Bank and WHO.

TDR established its Career Development Fellowship on Clinical Research & Development in 2009. Successful candidates are seconded to leading pharmaceutical companies in order to to develop their clinical trial management skills. Each of the qualified professionals accepted as a Fellow trains for 12 months on location at a facility of their hosting company’s, in order to develop specialized skills not readily taught in academic centres, including research and development (R&D) project management, regulatory requirements and clinical good practice. Upon completing their Fellowships, the individuals are expected to return to their home institute and assume a leading role in the global effort on R&D for infectious diseases, thereby enhancing developing country product development capacity on diagnostics, drugs and vaccines for the diseases that disproportionately affect poor and marginalized populations building.

• Innovation prizes and grants• Bill and Melinda Gates Foundation

WESTERN RESEARCH RE EBOLA• Zmapp - an experimental drug developed by a US

biotech firm Mapp Biopharmaceutical Inc. (over a decade)

• Tekmira Pharmaceuticals (Canada), Sarepta Therapeutics (US) and Profectus BioSciences, of Tarrytown, NY.

• MSF and Red Cross – return of infected aid workers• Donations – GSK, Johnson & Johnson, Novartis,

Bayer, Pfizer etc. 

AFRICA – RESEARCH AND FUNDING• Congo• % devoted to research – Health workers on

strike in Nigeria, Insufficient health workers in Sierra Leone

• Independence vs Dependence for Aid• Sense of entitlement – West (Big brother),

Grants• Indigenous drugs vs Generics (Brazil and China)• Patent protection – India and Evergreening

• Compulsory Licensing – Article 31bis TRIPS, Doha Declaration, Rwanda-Canada Apotex

i. authorization on the individual meritsii. payment of adequate remunerationiii. unsuccessful efforts to obtain an authorization

from the patent-holder on reasonable commercial terms within a reasonable period of time

iv. Public health emergencyv. Supply of domestic market• Voluntary Licensing – Gilead’s Sovaldi

HUMAN RIGHTS• Right to Health - right to the highest

attainable standard of physical and mental health, which includes access to all medical services, sanitation, adequate food, decent housing, healthy working conditions, and a clean environment. (UDHR Article 25)

• Right to highest attainable standard of physical and mental health – Accessibility, Availability, Acceptability and Quality (ICESCR Article 12)

Health – state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. (WHO)

State-guaranteed rights.

Availability: A sufficient quantity of functioning public health and health care facilities, goods and services, as well as programmes. Accessibility: Health facilities, goods and services accessible to everyone. Accessibility has four overlapping dimensions:

non-discrimination physical accessibility economical accessibility

(affordability) information accessibility.

Acceptability: All health facilities, goods and services must be respectful of medical ethics and culturally appropriate as well as sensitive to gender and life-cycle requirements. Quality: Health facilities, goods and services must be scientifically and medically appropriate and of good quality.

• Right to Development -Everyone has the right to enjoy the benefits of scientific progress and its applications. The World Conference on Human Rights notes that certain advances, notably in the biomedical and life sciences as well as in information technology, may have potentially adverse consequences for the integrity, dignity and human rights of the individual, and calls for international cooperation to ensure that human rights and dignity are fully respected in this area of universal concern. (Vienna Declaration para 11)

• Right to Culture - The States Parties to the present Covenant recognize the right of everyone:

(a) To take part in cultural life; (b) To enjoy the benefits of scientific progress

and its applications; (c) To benefit from the protection of the moral

and material interests resulting from any scientific, literary or artistic production of which he is the author. (ICESCR Article 15)

IP VERSUS HR• Patent monopoly• Economic rights – cost of research (high

costs justifiable?)• Ethics

CLINICAL TRIALS• Dr Kent Brantly and Nancy Writebol• Abdullahi v Pfizer Inc case in Kano, Nigeria

where 11 children died in a clinical trial for Pfizer’s Trojan – an antibiotic aimed at treating meningitis

• US National Institutes of Health (NIH) and GlaxoSmithKline – UK, Gambia and Mali

• Johnson & Johnson• GSK• (Healthy Volunteers)

• Fast-tracking trials of experimental drugs and vaccine candidates – FDA Approval

• Facilitates the development, and expedites the review, of drugs which treat a serious or life-threatening condition and fill an unmet medical need.

• Accelerated approval is meant for drugs that demonstrate an effect on a surrogate, or intermediate endpoint reasonably likely to predict clinical benefit.

• Priority review shortens the FDA review process for a new drug from ten months to six months, and is appropriate for drugs that demonstrate significant improvements in both safety and effectiveness of an existing therapy.

FINAL THOUGHTSIS THERE REALLY INSUFFICIENT

RESEARCH RE 10/90 GAP?

THANK YOU

QUESTIONS